Description
- ISBN-13: 978-1351261470
- Edition: 3rd
- Publisher: CRC Press
- Accessibility: Learn more
- Publication date: 2 August 2019
- Language: English
- File size: 7.2 MB
Availability: In Stock
Design Controls for the Medical Device Industry, Third Edition
SKU: 9780815365525
Original price was: ₹19,717.50.₹15,774.00Current price is: ₹15,774.00.
Navigate the complex world of medical device regulations with “Design Controls for the Medical Device Industry, Third Edition.” This comprehensive guide offers a deep dive into the latest design control requirements, providing essential tools and techniques for a compliant and effective program. Stay ahead of industry standards and meet the stringent expectations of the US FDA, Notified Bodies, and other global regulators. Essential for professionals seeking to develop robust design control systems that align with QSR and ISO 13485:2016, this book covers critical elements from planning and input to verification, validation, and change control. It uniquely integrates risk management, human factors, usability, and biocompatibility, offering practical advice, templates, and updated insights for successful implementation in the US, Canada, and Europe. This edition is your key resource for maintaining compliance and ensuring product safety in the medical device industry. A must-read from The Bookish Owl.
5 in stock
